Associate Director – Analytical Development (Molecular Biology)

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 01/01/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.

We are rapidly translating our specific, efficient, and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.

Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

About the position:

  • Oversee the development, optimization, and qualification/validation of robust molecular assays:
    • NGS, qPCR, ddPCR and other molecular assay platforms for the characterization of cell and gene therapy drug products, vector, and critical starting material
    • Evaluation of nucleic acid characteristics like residual impurity DNA, residual AAV and sgRNA
    • Gene editing features like on- and off-target editing, etc.
    • sgRNA sequencing
  • Provide expertise for enhancing existing assays, and implementation of new ideas and technologies
  • Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
  • Represent the analytical development team in cross-functional CMC meetings, and actively participate in strategy design, execution, data presentation and follow-up.
  • Form active collaboration with other teams within Analytical Development, Process development, Research and Quality teams.
  • Collaborate with external partners, CMOs to lead or monitor outsourcing activities, manage timelines, and ensure deliverables.
  • Author technical reports, protocols, and analytical sections of regulatory filings for US, Europe, and ROW.

Qualification Required:

  • MS/Ph.D. in molecular biology, or related sciences such as cell biology, genetics, or immunology
  • Minimum 8 years (Ph.D.) or 15 years (MS) of biopharma industry experience with demonstrated track record of successfully developing different molecular biology analytical methods using techniques like next-generation sequencing (NGS) platforms, Sanger sequencing, qPCR, droplet digital PCR (ddPCR)
    • Next-generation sequencing (NGS) experience and proficiency with various molecular biology and sequence analysis software is required
    • Experiences with bioinformatics programming is a plus
  • Strong knowledge of CRISPR gene editing, and analytical methods for cell and gene therapy products is required
    • Extensive knowledge and strong scientific background related to the products and underlying biology, applicability of the emerging or existing molecular assay platforms
  • Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate GMP requirements is required.
  • Prior experience of IND, BLA or equivalent regulatory filings is highly preferred.
  • Experiences with analytical or statistical software (e.g., JMP, Softmax Pro, Gen5 etc.), is highly desirable.
  • Experience of working with and managing external vendors/ CROs is preferred.
  • Experience working with LIMS is preferred
  • Experience working with automation of analytics is preferred
  • Strong writing, reviewing, and presentation skills is required.
  • Must have strong organization skills, and experience of mentoring Ph.D.-level scientists is required.
  • Ability to multi-task in a fast-paced environment with changing priorities.
  • Highly motivated, detail oriented with good problem-solving ability.

Competencies

  •  Collaborative – Openness, One Team
  •  Undaunted – Fearless, Can-do attitude
  •  Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  •  Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.